changing lives.
This position is responsible for all quality assurance and control activities for manufacturing site and ensure support for other manufacturing departments in the field of quality related processes like: CAPA, audit, complaint handling, supplier evaluation etc.
In this role, you will…
- In his/her role- support business in product quality and environmental aspects in dedicated area (SLA/AFAB/CSP/Shipping/ Warehousing)
- local partner for discussion for the business in PS groups / PFMEAs/ NCs/ CAPAs in relation to product quality and safety/ env conditions
- define requirements for process changes, validation purposes as interface with local teams
- interpret and apply applicable regulatory agency regulations and industry standards
- knowledge exchange and unify approach/ procedures across Align sites and partner for discussion with other Align sites
- Identify, analyze and lead the implementation of continuous opportunities of improvement (process and/or quality) focused on exceeding customer needs.
- Supporting internal and cross-functional teams in process quality improvement efforts.
- Ensure that appropriate quality documentation is in place, implemented and effective and improve quality documentation based on needs.
- Coordinate complaint handling and root cause investigation for local departments at the facility.
- Responsible for working with appropriate staff from various department to investigate root causes, put corrective action in place, and monitor results (coordinates CAPA activities locally).
- Carry out or participate in risk analysis regarding process, product or design.
- Be involved in any Corporate or outside agency inspections relating to Quality Management System, if required.
- Carry out and participate the audits (internal, supplier ones) in order to verify the Quality Management System compliance.
- Responsible for ensuring that appropriate quality controls are in place in the process.
- Participate in proactive team efforts to achieve departmental and company goals.
- Serves as general subject matter expert for quality processes & project teams.
- Supports, guides, and coaches the process owners and stake holders.
- Ensures the effective fulfillment of quality objectives and deadlines assigned.
- Ensure site document control procedures comply with local or country specific regulations as well as internal policies and procedures, translations of documents must be controlled.
- Be responsible for maintaining and ensuring the site change control process in Align EDMS, including the review of change control documents and deliverables.
- Review and assist in resolution of documentation issues (e.g. change control, document archiving, procedures, etc.) and translations.
- Review all electronic documents submitted to change control for correct formatting, spelling and clarity of text before obtaining approval.
- Co-administration of Aligns EDMS documentation system.
- Create and maintain all hard and soft copy master files for active and archival documentation.
- Perform other duties as assigned.
In this role, you’ll need …
- Bachelor degree in relevant area (chemistry, engineering, quality) required as minimum
- Post graduate studies related to Quality Management area nice to have
- Minimum of 3+ years of experience in a quality/compliance role (Medical or other regulated areas)
- A broad understanding of the Quality System regulations for medical devices (21 CFR, ISO 13485, MDR 2017/745, GMP, etc.).
- Strong written and oral communication abilities required and ability to synthesize information to present as requested.
- Fluent English and Polish required (reading, writing, and conversation).
- Practical knowledge of problem solving tools
- Production processes and validation methods knowledge
- Statistics (Minitab) and SPC knowledge
- ISO 13485 knowledge
- Very good MS Office tools skills (MS Project as well)
- Goal achieving focus
- Black Belt/Green Belt certificate nice to have
- ISO 13485 Internal Auditor certificate nice to have
Work environment demands
- Strong interpersonal communication skills with ability to build relationships
- Open minded, stress resistant person with ability to work in interdisciplinary teams.
- Independence and ability to work under time pressure
- High level interpersonal skills.
- Ability to consistently follow through with projects to completion.
- Ability to perform in a fast-changing environment
- Duty travel might be required.
We encourage you to familiarise yourself with our Signaller Procedure.You can find detailed information by clicking on the link below:
